510(k) K790583 ยท LCP Assay, Glycosylated Hemoglobin
QUIK COLUMN METHODOLOGY
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 23, 1979 |
| Received | Mar 27, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K790583
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.